WART FREEZE— 510(k) K130599

Substantially Equivalent

Koninklijke Utermohlen NV

FDA 510(k) clearance K130599 for WART FREEZE, Substantially Equivalent on 2013-06-05. Applicant: Koninklijke Utermohlen NV.

Clearance details

Applicant: Koninklijke Utermohlen NV
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2013-03-07
Decision date: 2013-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.